CHROMIC GUT SUTURE

FDA Premarket Approval N84381 S007

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceCHROMIC GUT SUTURE
Generic NameSuture, Absorbable, Natural
ApplicantDEKNATEL, INC.
Date Received1987-12-30
Decision Date1989-01-31
PMAN84381
SupplementS007
Product CodeGAL 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address DEKNATEL, INC. 600 Airport Rd. fall River, MA 02720

Supplemental Filings

Supplement NumberDateSupplement Type
N84381Original Filing
S008 1988-03-31 Normal 180 Day Track
S007 1987-12-30 Normal 180 Day Track
S006 1987-09-18 Normal 180 Day Track
S005 1984-06-21
S004 1984-05-09
S003 1983-04-14
S002 1981-04-08
S001 1981-02-05

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